| CTRI Number |
CTRI/2024/09/073211 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
31/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two treatment modalities in patients of Carpal Tunnel Syndrome. |
|
Scientific Title of Study
|
Prospective evaluation of pain relief and dynamic mobility of median nerve, using ultrasound following corticosteroid injection and carpal tunnel release in patients with carpal tunnel syndrome. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Shivani Rastogi |
| Designation |
Professor (Junior Grade) |
| Affiliation |
Dr RMLIMS |
| Address |
Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow
Department of Pain Medicine
OPD 3, Room number 3
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8176007201 |
| Fax |
|
| Email |
neuromanu@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shivani Rastogi |
| Designation |
Professor (Junior Grade) |
| Affiliation |
Dr RMLIMS |
| Address |
Dr RAM Manohar Lohia Institute of Medical Sciences, Lucknow
Department of Pain Medicine
OPD3, Room number 03
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8176007201 |
| Fax |
|
| Email |
neuromanu@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Shivani Rastogi |
| Designation |
Professor (Junior Grade) |
| Affiliation |
Dr RMLIMS |
| Address |
Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow
Department of Pain medicine, OPD 3
Room number 03
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8176007201 |
| Fax |
|
| Email |
neuromanu@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow (Uttar Pradesh), 226010, Country |
|
|
Primary Sponsor
|
| Name |
Dr RMLIMS |
| Address |
Gomti Nagar, Lucknow 226010 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shubhi Shukla |
Dr Ram Manohar Lohia Institute of Medical Sciences |
1.Pain Medicine OPD, Room no 7
2. Neurology OPD, Room no 10
3. Orthopaedic OPD, Room no 3
Lucknow
UTTAR PRADESH |
7976617140
shuklashubhi10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Dr RMLIMS, Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G560||Carpal tunnel syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Corticosteroid Injection therapy |
Comparison of functional outcome in patients of carpal tunnel who have undergone corticosteroid injection therapy and carpal Tunnel release surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
- Clinical diagnosis of Carpal Tunnel Syndrome, with duration more than six months not responding to conservative measures including non-steroidal anti-inflammatory drugs (NSAIDS),
- Patient willing to participate in the study after proper Informed Consent taking. |
|
| ExclusionCriteria |
| Details |
- Earlier surgery like Ultrasound Guided Carpal Tunnel Release or Open Carpal Tunnel Release,
- Local Corticosteroid injection within the last 6 months,
- Patients who have received Platelet Rich Plasma Therapy for Carpal Tunnel Syndrome.
- Physical therapy within 6 weeks, image proved rupture or conditions in which non-steroidal
anti-inflammatory drugs were used within 1 week,
- History of severe anemia (Hemoglobin less than 5),
- Thrombocytopenia or Bleeding tendency,
- Vascular insufficiency (Impalpable Radial Pulse)
- Neuropathy which is related to pain. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of Improvement in the Pain levels of the patient undergoing the two interventions by VAS Score and BCTQ Scale. |
1. Before procedure
2. Right after procedure
3. 1 week
4. 1 month
5. 3 months
6. 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Median nerve crosssectional area and mobility using ultrasonographic measurement. |
Ultrasonographic assessment pre and post intervention at different time intervals up to 6 months. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Carpal tunnel syndrome is the most common peripheral nerve entrapment syndrome worldwide. The clinical symptoms and physical examination findings in patients with this syndrome are recognised widely, and various treatments exist, including non-surgical and surgical options. Damage to the median nerve within the carpal tunnel gives rise to carpal tunnel syndrome (CTS), associated with a broad spectrum of symptoms In this era of evidence-based medicine, randomized controlled clinical trials (RCTs) are highly valued because known and unknown confounding variables will be randomly distributed between the two types of interventional therapies used in the treatment of Carpal Tunnel, that is, local and non-invasive corticosteroid therapy based versus surgical. This study aims at determining the efficacy of the two therapies and there long term effects with respect to both, pain relief as well as median nerve parameters on Ultrasonographic examination. |